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510(k) Data Aggregation
(84 days)
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are available in discs shape, and in various specifications, which are combinations of height (1025mm), color model (0M1/A1A4/B1B4/C1C4/D2~D4) and transparency model (T41/T45/T49/TR).
This document is a 510(k) Premarket Notification for a dental material, not a medical device involving AI or software. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like human reader improvement with AI assistance) is not applicable to this submission.
Here's a breakdown of why many of your questions cannot be answered from the provided text:
- No AI or Software: The device, "Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank," is a material for dental restorations. It does not involve any artificial intelligence, machine learning, or software components that would have performance metrics like sensitivity, specificity, or AUC, or require a ground truth established by experts.
- No Diagnostic or Interpretive Task: This device is a component used in manufacturing, not a diagnostic tool that interprets data or images.
- No Clinical Study for Performance Evaluation: The document explicitly states: "No clinical study is included in this submission." This means there is no human-in-the-loop performance evaluation or comparison against human experts.
However, I can extract information related to the performance testing that was conducted for this material:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here refer to the performance standards and biocompatibility tests for the material itself, not diagnostic accuracy. The reported device performance indicates conformance to these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Material Properties | ||
| Type and Class per | Type II Class 5 | Type II Class 5 |
| ISO 6872:2015 | ||
| Chemical Composition | ZrO2 ≥ 99.0%, Inorganic Pigment (Fe2O3, Er2O3) ≤ 1% | ZrO2 > 99.0%, Inorganic Pigment (Al2O3, SiO2, Fe2O3, Er2O3) < 1% |
| Crystal Morphology | Tetragonal | Tetragonal |
| Density | 6.00 g/cm³ | 6.00 g/cm³ |
| Sintering temperature | 1500 ± 50°C | 1500 ± 50°C |
| Performance | Comply with ISO 6872 | Comply with ISO 6872 |
| Biocompatibility | ||
| Cytotoxicity | No adverse reaction identified (Tested) | No adverse react identified (Tested per ISO 10993-5:2009) |
| Intracutaneous Reactivity | No adverse reaction identified (Tested) | No adverse react identified (Tested per ISO 10993-10:2010) |
| Sensitization | No adverse reaction identified (Tested) | No adverse react identified (Tested per ISO 10993-10:2010) |
| Acute Systemic Toxicity | No adverse reaction identified (Tested) | No adverse react identified (Tested per ISO 10993-11:2006) |
| Genotoxicity | No adverse reaction identified (Tested) | No adverse react identified (Tested per ISO 10993-3:2014) |
2. Sample size used for the test set and the data provenance:
- This information is not provided in a way that relates to "test sets" for diagnostic performance. For the material properties and biocompatibility tests, the sample sizes and specific types of samples (e.g., number of discs tested for density) are not detailed in this summary. The data provenance is internal testing conducted by the manufacturer to demonstrate compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" to be established by experts in the context of diagnostic accuracy for this material. The tests are chemical, physical, and biological assessments of the material itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No diagnostic adjudication method is relevant to material property and biocompatibility testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the diagnostic sense. For material properties, the "ground truth" is established by verifiable scientific measurement against established international standards (e.g., ISO 6872 for ceramic materials, ISO 10993 for biocompatibility).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a 510(k) summary for a dental material, not an AI or software-based medical device. Therefore, most of the questions relating to AI performance metrics, expert adjudication, and ground truth establishment for diagnostic purposes are irrelevant to this specific submission. The "acceptance criteria" and "performance" discussed are related to the material's physical, chemical, and biological properties.
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